Imd having a core circuitry support structure

ABSTRACT

A medical device includes a hybrid circuitry assembly and a core circuitry support structure. The core circuitry support structure includes a frame defining a cavity configured to receive at least a portion of the hybrid circuitry assembly. An outer surface of the frame is shaped to correspond to an inside surface of a core assembly housing configured to enclose the hybrid circuitry assembly and the core circuitry support structure.

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a Continuation Application which claims priority toU.S. patent application Ser. No. 17/132,296, filed Dec. 23, 2020, whichis a Continuation Application which claims priority to U.S. patentapplication Ser. No. 16/746,706, filed Jan. 17, 2020, now U.S. Pat. No.10,881,016, which is a Continuation Application which claims priority toU.S. patent application Ser. No. 16/356,858, filed Mar. 18,2019, nowU.S. Pat. No. 10,542,633, issued Jan. 21, 2020, which is a ContinuationApplication which claims priority to U.S. patent application Ser. No.15/489,603 filed Apr. 17, 2017, now issued U.S. Pat. No. 10,542,633,which claims priority to Provisional Application 62/324,202, filed Apr.18, 2016, which is herein incorporated by reference in its entirety.

TECHNICAL FIELD

Embodiments of the present disclosure relate to medical devices andsystems for sensing physiological parameters and/or delivering therapy.More specifically, embodiments of the disclosure relate to design ofcontrol circuitry support structures of implantable medical devices.

BACKGROUND

Implantable medical devices (IMDs) may be configured to sensephysiological parameters and/or provide therapy and may include one ormore electrodes for performing aspects of these functions. Constructionof IMDs often involves challenges regarding locating circuitry so thatinterconnections can be made in a repeatable manner, positionallocations are maintained, and ease of manufacturing is increased.

SUMMARY

Embodiments of the disclosure include an implantable medical devicehaving a core circuitry support structure that facilitates locating thecore circuitry in space to improve repeatability of interconnections,reliability of spatial location, and ease of manufacture.

In an Example 1, a medical device comprising: a hybrid circuitryassembly; and a core circuitry support structure, comprising: a framedefining a cavity configured to receive at least a portion of the hybridcircuitry assembly, wherein an outer surface of the frame is shaped tocorrespond to an inside surface of a core assembly housing configured toenclose the hybrid circuitry assembly and the core circuitry supportstructure.

In an Example 2, the medical device of Example 1, the hybrid circuitryassembly comprises a printed circuit board (PCB) having a first surfaceand a second, parallel surface.

In an Example 3, the medical device of either of Examples 1 or 2, theframe comprising: a first end wall; a second, opposite end wall; and apair of parallel, opposed side walls, wherein the first end wall, secondend wall, and side walls define the cavity.

In an Example 4, the medical device of any of Examples 1-3, the framecomprising at least one alignment feature, the at least one alignmentfeature configured to facilitate alignment of the hybrid circuitryassembly with the core circuitry support structure.

In an Example 5, the medical device of Example 4, the PCB comprising atleast one alignment notch, wherein the at least one alignment notch isconfigured to receive the at least one alignment feature.

In an Example 6, the medical device of either of Examples 4 or 5, the atleast one alignment feature comprising: a first alignment feature havinga first shape a first size; and a second alignment feature having asecond shape and a second size, wherein: the second shape is differentthan the first shape, and/or the second size is different than the firstsize.

In an Example 7, the medical device of any of Examples 2-6, the corecircuitry support structure comprising a shelf extending at leastpartially around a perimeter of the core circuitry support structure,wherein the shelf is configured to engage a peripheral edge of the firstsurface of the PCB.

In an Example 8, the medical device of any of Examples 2-7, the hybridcircuitry assembly further comprising: a first set of additionalcircuitry components coupled to the first side of the PCB; and a secondset of additional circuitry components coupled to the second side of thePCB.

In an Example 9, the medical device of any of Examples 3-8, wherein thecore circuitry support structure comprises a panel coupled to the firstend wall, second end wall and side walls, wherein the first end wall,second end wall, and side walls define the cavity.

In an Example 10, the medical device of either of Examples 8 or 9,further comprising a cover configured to be disposed over the second setof additional circuitry components, the cover comprising an outersurface shaped to correspond to the inner surface of the core assemblyhousing.

In an Example 11, the medical device of either of Examples 9 or 10, thepanel comprising a recess defined in an outside surface of the panel,the recess configured to receive an X-ray identification tag.

In an Example 12, a medical device comprising: a header having a firstend and a second end; a feed-through assembly coupled to the second endof the header; and a core assembly coupled, at a first end, to thefeed-through assembly, the core assembly comprising: a core assemblyhousing enclosing an interior space; a core circuitry assembly disposedin the interior space, the core circuitry assembly comprising: a hybridcircuitry assembly; and a core circuitry support structure, the corecircuitry support structure comprising a frame defining a cavity that isconfigured to receive at least a portion of the hybrid circuitryassembly.

In an Example 13, the medical device of Example 12, the hybrid circuitryassembly comprising a printed circuit board (PCB) having a first surfaceand a second, parallel surface, wherein the core circuitry supportstructure includes at least one alignment feature, the at least onealignment feature configured to facilitate alignment of the hybridcircuitry assembly with the core circuitry support structure.

In an Example 14, the medical device of Example 13, the PCB comprisingat least one alignment notch, wherein the at least one alignment notchis configured to receive the at least one alignment feature.

In an Example 15, a method of manufacturing a medical device,comprising: providing a hybrid circuitry assembly; forming a corecircuitry support structure, the core circuitry support structurecomprising at least one of an alignment feature configured to facilitatealignment of the hybrid circuitry assembly with the core circuitrysupport structure and a retaining clip configured to engage at least aportion of the hybrid circuitry assembly; coupling the hybrid circuitryassembly to the core circuitry support structure to form a corecircuitry assembly; positioning a first portion and a second portion ofa core assembly housing around the core circuitry assembly; and weldingthe first and second portions together.

In an Example 16, a medical device comprising: a hybrid circuitryassembly comprising a printed circuit board (PCB) having a first surfaceand a second, parallel surface; and a core circuitry support structure,comprising: a frame defining a cavity configured to receive at least aportion of the hybrid circuitry assembly, wherein an outer surface ofthe frame is shaped to correspond to an inside surface of a coreassembly housing configured to enclose the hybrid circuitry assembly andthe core circuitry support structure.

In an Example 17, the medical device of Example 16, the framecomprising: a first end wall; a second, opposite end wall; and a pair ofparallel, opposed side walls, wherein the first end wall, second endwall, and side walls define the cavity.

In an Example 18, the medical device of Example 17, the frame comprisingat least one alignment feature, the at least one alignment featureconfigured to facilitate alignment of the hybrid circuitry assembly withthe core circuitry support structure.

In an Example 19, the medical device of Example 18, the PCB comprisingat least one alignment notch, wherein the at least one alignment notchis configured to receive the at least one alignment feature.

In an Example 20, the medical device of Example 19, the at least onealignment feature comprising: a first alignment feature having a firstshape a first size; and a second alignment feature having a second shapeand a second size, wherein: the second shape is different than the firstshape, and/or the second size is different than the first size.

In an Example 21, the medical device of Example 16, the core circuitrysupport structure comprising a shelf extending at least partially arounda perimeter of the core circuitry support structure, wherein the shelfis configured to engage a peripheral edge of the first surface of thePCB.

In an Example 22, the medical device of Example 17, the hybrid circuitryassembly further comprising: a first set of additional circuitrycomponents coupled to the first side of the PCB; and a second set ofadditional circuitry components coupled to the second side of the PCB.

In an Example 23, the medical device of Example 22, wherein the corecircuitry support structure comprises a panel coupled to the first endwall, second end wall and side walls, wherein the first end wall, secondend wall, and side walls define the cavity.

In an Example 24, the medical device of Example 22, further comprising acover configured to be disposed over the second set of additionalcircuitry components, the cover comprising an outer surface shaped tocorrespond to the inner surface of the core assembly housing.

In an Example 25, the medical device of Example 17, the panel comprisinga recess defined in an outside surface of the panel, the recessconfigured to receive an X-ray identification tag.

In an Example 26, a medical device comprising: a header having a firstend and a second end; a feed-through assembly coupled to the second endof the header; and a core assembly coupled, at a first end, to thefeed-through assembly, the core assembly comprising: a core assemblyhousing enclosing an interior space; a core circuitry assembly disposedin the interior space, the core circuitry assembly comprising: a hybridcircuitry assembly; and a core circuitry support structure, the corecircuitry support structure comprising a frame defining a cavity that isconfigured to receive at least a portion of the hybrid circuitryassembly.

In an Example 27, the medical device of Example 26, the hybrid circuitryassembly comprising a printed circuit board (PCB) having a first surfaceand a second, parallel surface, wherein the core circuitry supportstructure includes at least one alignment feature, the at least onealignment feature configured to facilitate alignment of the hybridcircuitry assembly with the core circuitry support structure.

In an Example 28, the medical device of Example 27, the PCB comprisingat least one alignment notch, wherein the at least one alignment notchis configured to receive the at least one alignment feature.

In an Example 29, the medical device of Example 27, the at least onealignment feature comprising: a first alignment feature having a firstshape a first size; and a second alignment feature having a second shapeand a second size, wherein: the second shape is different than the firstshape, and/or the second size is different than the first size.

In an Example 30, the medical device of Example 27, the core circuitrysupport structure comprising a shelf extending at least partially arounda perimeter of the core circuitry support structure, wherein the shelfis configured to engage a peripheral edge of the first surface of thePCB.

In an Example 31, the medical device of Example 27, the hybrid circuitryassembly further comprising: a first set of additional circuitrycomponents coupled to the first side of the PCB; and a second set ofadditional circuitry components coupled to the second side of the PCB.

In an Example 32, the medical device of Example 31, the framecomprising: a first end wall; a second, opposite end wall; and a pair ofparallel, opposed side walls, wherein the first end wall, second endwall, and side walls define the cavity.

In an Example 33, the medical device of Example 31, further comprising acover configured to be disposed over the second set of additionalcircuitry components, the cover comprising an outer surface shaped tocorrespond to the inner surface of the core assembly housing.

In an Example 34, the medical device of Example 32, the panel comprisinga recess defined in an outside surface of the panel, the recessconfigured to receive an X-ray identification tag.

In an Example 35, a method of manufacturing a medical device,comprising: providing a hybrid circuitry assembly; forming a corecircuitry support structure, the core circuitry support structurecomprising an alignment feature configured to facilitate alignment ofthe hybrid circuitry assembly with the core circuitry support structure;coupling the hybrid circuitry assembly to the core circuitry supportstructure to form a core circuitry assembly; positioning a first portionand a second portion of a core assembly housing around the corecircuitry assembly; and welding the first and second portions together.

While multiple embodiments are disclosed, still other embodiments of thepresent disclosure will become apparent to those skilled in the art fromthe following detailed description, which shows and describesillustrative embodiments of the disclosure. Accordingly, the drawingsand detailed description are to be regarded as illustrative in natureand not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a schematic illustration depicting a patient monitoringsystem, in accordance with embodiments of the disclosure.

FIG. 2A is a perspective view of an implantable medical device (IMD), inaccordance with embodiments of the disclosure.

FIGS. 2B and 2C are partially-exploded perspective views of the IMDdepicted in FIG. 2A, in accordance with embodiments of the disclosure.

FIG. 2D is a side view of the IMD depicted in FIGS. 2A-2C, with the coreassembly housing removed, in accordance with embodiments of thedisclosure.

FIG. 2E is a side view of the IMD depicted in FIGS. 2A-2D, with the coreassembly housing shown as transparent, in accordance with embodiments ofthe disclosure.

FIG. 3A is a perspective view of a core circuitry support structure, inaccordance with embodiments of the disclosure.

FIG. 3B is another perspective view of the core circuitry supportstructure depicted in FIG. 3A, in accordance with embodiments of thedisclosure.

FIG. 3C is a side view of the core circuitry support structure depictedin FIGS. 3A and 3B, in accordance with embodiments of the disclosure.

FIG. 3D is a top view of the core circuitry support structure depictedin FIGS. 3A-3C, in accordance with embodiments of the disclosure.

FIG. 3E is a front view of the core circuitry support structure depictedin FIGS. 3A-3D, in accordance with embodiments of the disclosure.

FIG. 4A is a close-up top view of the IMD depicted in FIGS. 2A-2E, withthe core assembly housing removed, in accordance with embodiments of thedisclosure.

FIG. 4B is a close-up perspective view of the IMD depicted in FIGS.2A-2E, with the core assembly housing removed, in accordance withembodiments of the disclosure.

FIG. 4C is a side view of the IMD depicted in FIGS. 2A-2E, with the coreassembly housing removed, in accordance with embodiments of thedisclosure.

FIG. 4D is a side view of the IMD depicted in FIGS. 2A-2E, with the coreassembly housing removed and the core circuitry support structure shownas transparent, in accordance with embodiments of the disclosure.

FIGS. 4E and 4F are cross-sectional perspective views of the IMDdepicted in FIGS. 2A-2E, with the core assembly housing removed, inaccordance with embodiments of the disclosure.

FIG. 4G is a close-up perspective view of the IMD depicted in FIGS.2A-2E, with the core assembly housing and hybrid circuitry assemblyremoved, in accordance with embodiments of the disclosure.

FIGS. 5A and 5B are perspective views of a core circuitry assembly,showing application of an X-ray identification tag, in accordance withembodiments of the disclosure.

FIGS. 6A and 6B are perspective views of a core circuit supportstructure, in accordance with embodiments of the disclosure.

FIG. 7 is a flowchart depicting an illustrative method of assembling anIMD, in accordance with embodiments of the disclosure.

While the disclosed subject matter is amenable to various modificationsand alternative forms, specific embodiments have been shown by way ofexample in the drawings and are described in detail below. Theintention, however, is not to limit the disclosed subject matter to theparticular embodiments described. On the contrary, the disclosed subjectmatter is intended to cover all modifications, equivalents, andalternatives falling within the scope of the disclosed subject matter asdefined by the appended claims.

As the terms are used herein with respect to ranges of measurements(such as those disclosed immediately above), “about” and “approximately”may be used, interchangeably, to refer to a measurement that includesthe stated measurement and that also includes any measurements that arereasonably close to the stated measurement, but that may differ by areasonably small amount such as will be understood, and readilyascertained, by individuals having ordinary skill in the relevant artsto be attributable to measurement error, differences in measurementand/or manufacturing equipment calibration, human error in readingand/or setting measurements, adjustments made to optimize performanceand/or structural parameters in view of differences in measurementsassociated with other components, particular implementation scenarios,imprecise adjustment and/or manipulation of objects by a person ormachine, and/or the like.

Although the term “block” may be used herein to connote differentelements illustratively employed, the term should not be interpreted asimplying any requirement of, or particular order among or between,various steps disclosed herein unless and except when explicitlyreferring to the order of individual steps.

DETAILED DESCRIPTION

FIG. 1 is a schematic illustration of a system 100 including animplantable medical device (IMD) 102 implanted within a patient's body104 and configured to communicate with a receiving device 106. Inembodiments, the IMD 102 may be implanted subcutaneously within animplantation location or pocket in the patient's chest or abdomen andmay be configured to monitor (e.g., sense and/or record) physiologicalparameters associated with the patient's heart 108. In embodiments, theIMD 102 may be an implantable cardiac monitor (ICM) (e.g., animplantable diagnostic monitor (IDM), an implantable loop recorder(ILR), etc.) configured to record physiological parameters such as, forexample, one or more cardiac activation signals, heart sounds, bloodpressure measurements, oxygen saturations, and/or the like. Inembodiments, the IMD 102 may be configured to monitor physiologicalparameters that may include one or more signals indicative of apatient's physical activity level and/or metabolic level, such as anacceleration signal. In embodiments, the IMD 102 may be configured tomonitor physiological parameters associated with one or more otherorgans, systems, and/or the like. The IMD 102 may be configured to senseand/or record at regular intervals, continuously, and/or in response toa detected event. In embodiments, such a detected event may be detectedby one or more sensors of the IMD 102, another IMD (not shown), anexternal device (e.g., the receiving device 106), and/or the like. Inaddition, the IMD 102 may be configured to detect a variety ofphysiological signals that may be used in connection with variousdiagnostic, therapeutic, and/or monitoring implementations.

For example, the IMD 102 may include sensors or circuitry for detectingrespiratory system signals, cardiac system signals, and/or signalsrelated to patient activity. In embodiments, the IMD 102 may beconfigured to sense intrathoracic impedance, from which variousrespiratory parameters may be derived, including, for example,respiratory tidal volume and minute ventilation. Sensors and associatedcircuitry may be incorporated in connection with the IMD 102 fordetecting one or more body movement or body posture and/or positionrelated signals. For example, accelerometers and/or GPS devices may beemployed to detect patient activity, patient location, body orientation,and/or torso position.

For purposes of illustration, and not of limitation, various embodimentsof devices that may be used to record physiological parameters inaccordance with the present disclosure are described herein in thecontext of IMDs that may be implanted under the skin in the chest regionof a patient. In embodiments, however, the IMD 102 may include any typeof IMD, any number of different components of an implantable system,and/or the like having a housing and being configured to be implanted ina patient's body 104. For example, the IMD 102 may include a controldevice, a monitoring device, a pacemaker, an implantable cardioverterdefibrillator (ICD), a cardiac resynchronization therapy (CRT) deviceand/or the like, and may be an implantable medical device known in theart or later developed, for providing therapy and/or diagnostic dataabout the patient's body and/or the IMD 102. In various embodiments, theIMD 102 may include both defibrillation and pacing/CRT capabilities(e.g., a CRT-D device).

As shown, the IMD 102 may include a housing 110 having two electrodes112 and 114 coupled thereto. According to embodiments, the IMD 102 mayinclude any number of electrodes (and/or other types of sensors such as,e.g., thermometers, barometers, pressure sensors, optical sensors,motion sensors, and/or the like) in any number of various types ofconfigurations, and the housing 110 may include any number of differentshapes, sizes, and/or features. In embodiments, the IMD 102 may beconfigured to sense physiological parameters and record thephysiological parameters. For example, the IMD 102 may be configured toactivate (e.g., periodically, continuously, upon detection of an event,and/or the like), record a specified amount of data (e.g., physiologicalparameters) in a memory, and communicate that recorded data to areceiving device 106. In the case of an IDM, for example, the IMD 102may activate, record cardiac signals for a certain period of time,deactivate, and activate to communicate the recorded signals to thereceiving device 106.

In various embodiments, the receiving device 106 may be, for example, aprogrammer, controller, patient monitoring system, and/or the like.Although illustrated in FIG. 1 as an external device, the receivingdevice 106 may include an implantable device configured to communicatewith the IMD 102 that may, for example, be a control device, anothermonitoring device, a pacemaker, an implantable defibrillator, a cardiacresynchronization therapy (CRT) device, and/or the like, and may be animplantable medical device known in the art or later developed, forproviding therapy and/or diagnostic data about the patient and/or theIMD 102. In various embodiments, the IMD 102 may be a pacemaker, animplantable cardioverter defibrillator (ICD) device, or a cardiacresynchronization therapy (CRT) device. In various embodiments, the IMD102 may include both defibrillation and pacing/CRT capabilities (e.g., aCRT-D device).

The system 100 may be used to implement coordinated patient measuringand/or monitoring, diagnosis, and/or therapy in accordance withembodiments of the disclosure. The system 100 may include, for example,one or more patient-internal medical devices, such as an IMD 102, andone or more patient-external medical devices, such as receiving device106. In embodiments, the receiving device 106 may be configured toperform monitoring, and/or diagnosis and/or therapy functions externalto the patient (i.e., not invasively implanted within the patient'sbody). The receiving device 106 may be positioned on the patient, nearthe patient, or in any location external to the patient.

In embodiments, the IMD 102 and the receiving device 106 may communicatethrough a wireless link. For example, the IMD 102 and the receivingdevice 106 may be coupled through a short-range radio link, such asBluetooth, IEEE 802.11, and/or a proprietary wireless protocol. Thecommunications link may facilitate uni-directional and/or bi-directionalcommunication between the IMD 102 and the receiving device 106. Dataand/or control signals may be transmitted between the IMD 102 and thereceiving device 106 to coordinate the functions of the IMD 102 and/orthe receiving device 106. In embodiments, patient data may be downloadedfrom one or more of the IMD 102 and the receiving device 106periodically or on command. The physician and/or the patient maycommunicate with the IMD 102 and the receiving device 106, for example,to acquire patient data or to initiate, terminate, or modify recordingand/or therapy.

The illustrative system 100 shown in FIG. 1 is not intended to suggestany limitation as to the scope of use or functionality of embodiments ofthe subject matter disclosed throughout this disclosure. Neither shouldthe illustrative system 100 be interpreted as having any dependency orrequirement related to any single component or combination of componentsillustrated in FIG. 1. For example, in embodiments, the illustrativesystem 100 may include additional components. Additionally, any one ormore of the components depicted in FIG. 1 can be, in embodiments,integrated with various ones of the other components depicted therein(and/or components not illustrated). Any number of other components orcombinations of components can be integrated with the illustrativesystem 100 depicted in FIG. 1, all of which are considered to be withinthe ambit of this disclosure.

FIG. 2A is a perspective view of an implantable medical device (IMD)200, in accordance with embodiments of the disclosure. The IMD 200 maybe, or may be similar to, the IMD 102 depicted in FIG. 1. As shown, theIMD 200 may include a header 202 arranged at or near a first end 220 ofa core assembly 204. A battery assembly 206 (which may include one ormore batteries) is arranged near a second end 224 of the core assembly204. The header 202 includes a housing 202A that encloses an interiorregion 202B. The header 202 may house various circuitry componentswithin its interior. The housing 202A may contact a patient's bodilytissue when the IMD 200 is subcutaneously implanted in an implantationlocation or pocket in the patient's chest or abdomen. The interiorregion 202B of the header 202 may house circuit components (e.g., anelectrode 208 and an antenna 210) positioned and supported by a scaffoldassembly 212. As shown, the IMD 200 may include, in addition to theelectrode 208, an electrode 214 disposed at an end of the batteryassembly 206. In embodiments, the electrode 214 may be integrated withthe battery assembly 206, a housing of the battery assembly 206, and/orthe like. In order to enable sensing of physiological parameters withinthe patient, the electrode 208 may be positioned to be flush with aninterior surface of the housing 202A of the header 202. In otherinstances, the electrode 208 may be positioned by the scaffold assembly212 to form a portion of an exterior surface of the housing 202A of theheader 202.

As shown in FIG. 2B, the core assembly 204 includes a core circuitryassembly 216 enclosed within a core assembly housing 218. The coreassembly housing 218 is coupled, at the first end 220, to a firstfeed-through assembly 222, and coupled, at the second end 224, to asecond feed-through assembly 226. The feed-through assembly 222 may beconfigured to provide a throughput for connections configured to connectthe circuitry components of the header 202 (e.g., the electrode 208 andthe antenna 210) to the core circuitry assembly 216. Similarly, thefeed-through assembly 226 may be configured to provide a throughput forconnections configured to connect one or more batteries (e.g., which area part of the battery assembly 206) and/or the electrode 214 to the corecircuitry assembly 216.

As illustrated in FIG. 2A, the core assembly housing 204 includes afirst portion 228 configured to be coupled to a second portion 230 alonga weld seam 232. The first portion 228 and second portion 230 may becoupled together by laser welding, seam welding, and/or the like. Inembodiments, a separate weld ring does not need to be used, as a featureof at least one of the first and second portions 228 and 230 acts as aweld ring, protecting the core circuitry assembly 216 from the weldingenergy (e.g., heat, laser, etc.).

For example, the first portion 228 may include one or more weld jointfeatures configured to be positioned adjacent to one or morecorresponding weld joint features on the second portion 230 inpreparation for welding. In embodiments, for example, the first portion228 and the second portion 230 may include a continuous, curved wall(such as, for example, in an implementation of a pacemaker or otherimplantable pulse generator), a curved wall and a straight wall, anumber of curved walls, a number of straight walls, and/or any number ofdifferent combinations of these. Each wall of the first portion 228 thatis configured to be coupled to a corresponding wall of the secondportion 230 may include at least one weld joint feature configured to bepositioned adjacent to at least one corresponding feature on the secondportion 230, and, in embodiments, vice-versa.

Each weld joint feature includes a thinned leading edge (the edge thatis configured to be coupled to the corresponding edge of the otherportion of the housing) of a wall. That is, the edge of the wall isthinner than other sections of the wall. In this manner, an edge of oneof the two portions can pass over the corresponding edge of the otherportion when the two portions are positioned around the core circuitryassembly in preparation for welding. In this manner, the volume enclosedwithin the housing may be maximized, and the lower edge (i.e., the edgecloser to the core circuitry assembly) acts as a weld ring, protectingthe core circuitry assembly from the applied energy (e.g., heat, laser,etc.) during a welding procedure. In embodiments, the weld joint featuremay include a coined edge of a wall, a flange, and/or the like.

As shown, for example, in FIGS. 2B and 2C, the first portion 228 of thecore assembly housing 218 includes a side wall 234, a lower wall 236,and an upper wall 238. The lower wall 236 and the upper wall 238 eachextend, perpendicularly (or at least approximately perpendicularly) in adirection away from an inside surface 234A of the side wall 234. Asshown, the lower wall 236 is coupled to the side wall 234 by a curvedcorner portion 240, and the upper wall 238 is coupled to the side wall234 by a curved corner portion 242. In embodiments, the curved cornerportions 240 and 242 may be integrated with the lower and upper walls236 and 238, respectively, the side wall 234, and/or the like. That is,for example, the first portion 228 may be a single piece of metal,formed in a press or a mold. In embodiments, the curved corner portions240 and 242 may be separate components. The curved corner portions 240and 242 each may be designed to have any desirable radius of curvature.For example, the curved corner portions 240 and 242 each may beconfigured to have a radius of curvature that provides a desired amountof volume enclosed within the core assembly housing 218.

As illustrated, for example, in FIGS. 2B and 2C, the lower wall 236includes a flange 244 that is recessed with respect to an inside surface246 of the lower wall 236, and that extends from a first end 248 of thefirst portion 228 to a second end 250 thereof. The flange 244 may be athinned portion of the lower wall 236. In embodiments, the flange 244may be welded to the lower wall 236. Similarly, the upper wall 238includes a flange 252 that is recessed with respect to an inside surface254 of the upper wall 238, and that extends from the first end 248 ofthe first portion 228 to the second end 250 thereof. The flange 252 maybe a thinned portion of the upper wall 238. In embodiments, the flange252 may be welded to the upper wall 238.

As is also shown, for example, in FIGS. 2B and 2C, the second portion230 of the core assembly housing 218 includes a side wall 256, a lowerwall 258, and an upper wall 260. The lower wall 258 and the upper wall260 each extend, perpendicularly (or at least approximatelyperpendicularly) in a direction away from an inside surface 256A of theside wall 256. As shown, the lower wall 258 is coupled to the side wall256 by a curved corner portion 262, and the upper wall 260 is coupled tothe side wall 256 by a curved corner portion 264. In embodiments, thecurved corner portions 262 and 264 may be integrated with the lower andupper walls 258 and 260, respectively, the side wall 256, and/or thelike. That is, for example, the second portion 230 may be a single pieceof metal, formed in a press or a mold. In embodiments, the curved cornerportions 262 and 264 may be separate components. The curved cornerportions 262 and 264 each may be designed to have any desirable radiusof curvature such as, for example, a radius of curvature that isidentical or similar to the radius of curvature of each of the curvedcorner portions 240 and 242. For example, the curved corner portions 262and 264 each may be configured to have a radius of curvature thatprovides a desired amount of volume enclosed within the core assemblyhousing 218.

As illustrated, for example, in FIGS. 2B and 2C, the lower wall 258includes a flange 266 that is recessed with respect to an outsidesurface 268 of the lower wall 258, and that extends from a first end 270of the second portion 230 to a second end 272 thereof. The flange 266may be a thinned portion of the lower wall 258. In embodiments, theflange 266 may be welded to the lower wall 258. Similarly, the upperwall 260 includes a flange 274 that is recessed with respect to anoutside surface 276 of the upper wall 260, and that extends from thefirst end 270 of the second portion 230 to the second end 272 thereof.The flange 274 may be a thinned portion of the upper wall 260. Inembodiments, the flange 274 may be welded to the upper wall 260. Thecore assembly housing 218 may also include notches 278 defined in thefirst and second ends 248 and 250, respectively, of the first portion228, and extending from the inside surface 234A to the outside surface234B of the side wall 234. Similarly, the core assembly housing 218 mayalso include notches 280 defined in the first and second ends 270 and272, respectively, of the second portion 230, and extending from theinside surface 256A to the outside surface 256B of the side wall 256.When the first portion 228 is brought together with the second portion230, the flange 244 is positioned adjacent to the flange 266, and theflange 252 is positioned adjacent to the flange 274. The portions 228and 230 are welded together along the flanges 244, 266 and 252, 274 toenclose the core circuitry assembly 216.

As shown in FIGS. 2B-2E, the core circuitry assembly 216 includes a corecircuitry support structure 282 disposed within the core assemblyhousing 218. A hybrid circuit assembly 284, which includes the corecircuitry such as, for example, a printed circuit board (PCB) and othercircuitry components, is coupled, on a first side (not shown in FIGS.2B-2E) of the hybrid circuit assembly 284 to the core circuitry supportstructure 282. A cover 286 is disposed over a second side 288 of thehybrid circuit assembly 284. The cover 286 may be configured accordingto any number of different shapes, including, for example, a shape thatcorresponds to the shape of the inside surfaces 234A, 246, and 254 ofthe first portion 234 of the core assembly housing 218. In embodimentsin which the core circuitry support structure 282 includes retainingclips 366, the cover 286 may include notches 380 corresponding to, andallowing room for, retaining clips 366 disposed on the core circuitrysupport structure 282. In embodiments, the cover 286 may include anynumber of other features configured to correspond to any number of otherfeatures of the core circuitry support structure 282, the core assemblyhousing 218, and/or other component of the IMD 200.

The core circuitry assembly 216 may be configured to enhance theavailable space within the core assembly. In embodiments, as shown, thecore circuitry support structure 282 may include an outside surface 290Aand the cover 286 may include an outside surface 290B. The outsidesurfaces 290A and 290B may be configured to align in at leastapproximately a same plane (or set of planes or curved surfaces) as afirst interface surface 292 defined on the first feed-through assembly222 and a second interface surface 294 defined on the secondfeed-through assembly 226. The first and second interface surfaces 292and 294 may extend around a perimeter of each of the first and secondfeed-through assemblies 222 and 226, respectively, and may extend atleast approximately orthogonally away from third and fourth interfacesurfaces 296 and 298, respectively, which also may extend around aperimeter of each of the first and second feed-through assemblies 222and 226, respectively.

During assembly, the first and second portions 228 and 230 of the coreassembly housing 218 are brought together such that the inside surface246 of the lower wall 236 of the first portion 228, the inside surface234A of the side wall 234 of the first portion 228, and the insidesurface 254 of the upper wall 238 of the first portion 228 interfacewith (e.g., are disposed in contact with) corresponding sections of thefirst and second interface surfaces 292 and 294; and a first edgesurface 300 and a second edge surface 302 of the first portion 228interface with the first and second interface surfaces 296 and 298,respectively. Similarly, during assembly, an inside surface 304 of thelower wall 258 of the second portion 230, the inside surface 256A of theside wall 256 of the second portion 230, and an inside surface 306 ofthe upper wall 260 of the second portion 230 interface with (e.g., aredisposed in contact with) corresponding sections of the first and secondinterface surfaces 292 and 294; and a first edge surface 308 and asecond edge surface 310 of the second portion 230 interface with thefirst and second interface surfaces 296 and 298, respectively. In thismanner, when the core assembly housing 218 is welded together, theinside surfaces of the core assembly housing 218 may interface with theoutside surface 290A of the core circuitry support structure 282 and theoutside surface 290B of the cover 286. In embodiments, the insidesurfaces of the core assembly housing 218 may not actually contact theoutside surfaces 290A and 290B of the core circuitry support structure282 and cover 286, respectively, but may be configured to reduce a gapbetween the surfaces. According to embodiments, the outside surfaces290A and 290B of the core circuitry support structure 282 and cover 286,respectively, may be designed to have shapes that correspond to theshapes of the inside surfaces of the core assembly housing 218.

In embodiments, the core circuitry support structure 282 and/or thecover 286 may be configured such that an air gap is formed adjacent tothe weld seam 232. The air gap may be provided by designing the corecircuitry support structure 282 and/or the cover 286 to have a certainperimeter. In embodiments, the air gap may be provided be designing achannel or thinned portion into the core circuitry support structure 282and/or the cover 286. The air gap may be less than 0.1 inches wide (asmeasured between an outside surface of the core circuitry supportstructure 282 or the cover 286 and an inside surface of the coreassembly housing 218. In embodiments, the air gap may be approximately0.010 inches wide, or any other desired width. In this manner, the airgap may facilitate preventing overheating of the core circuitry supportstructure 282 and/or the cover 286 during welding of the core circuitryassembly 218 together by reducing contact with the core assembly housing218 and by providing an insulation of air between the core circuitrysupport structure 282 and/or the cover 286 and the core assembly housing218. According to embodiments, aspects of the core circuitry supportstructure 282 may be designed to facilitate providing gaps of anydesired width between the outside surface 290A thereof and any number ofdifferent inside surfaces of the core assembly housing 218.

The illustrative IMD 200 shown in FIGS. 2A-2E is not intended to suggestany limitation as to the scope of use or functionality of embodiments ofthe subject matter disclosed throughout this disclosure. Neither shouldthe illustrative IMD 200 be interpreted as having any dependency orrequirement related to any single component, feature, or combination ofcomponents or features illustrated in FIGS. 2A-2E. For example, inembodiments, the illustrative IMD 200 may include different and/oradditional components and/or features. Any number of other components,features, or combinations of components or features can be integratedwith the illustrative IMD 200 depicted in FIGS. 2A-2E, all of which areconsidered to be within the ambit of this disclosure. Additionally, anyone or more of the components and/or features depicted in FIGS. 2A-2Ecan be, in embodiments, integrated with various ones of the othercomponents and/or features depicted therein (and/or components and/orfeatures not illustrated).

FIGS. 3A-3E depict various views of the core circuitry support structure282, in accordance with embodiments of the disclosure. FIGS. 4A-4Edepict various views of the core circuit assembly 216, and may bereferred to below to further clarify the description. As shown, the corecircuitry support structure 282 includes a first end 312 configured tobe disposed adjacent the first feed-through assembly 222, and a secondend 314 configured to be disposed adjacent the second feed-throughassembly 226. The core circuitry support structure 282 includes a frame316 having a first end wall 318 disposed at or near the first end 312 ofthe core circuitry support structure 282, a second end wall 320 disposedat or near the second end 314 of the core circuitry support structure282, and two parallel, opposed side walls 322 and 324 extending betweenthe first and second end walls 318 and 320. A panel 326, oriented atleast approximately perpendicular to the walls 318, 320, 322, and 324,extends between the first and second end walls 318 and 320, and iscoupled to the side walls 322 and 324 via curved corner walls 328 and330, respectively. In embodiments, the curved corner walls 328 and 330each may be designed to have any desirable radius of curvature such as,for example, a radius of curvature that is identical or similar to (orotherwise designed to complement/correspond to) the radius of curvatureof each of the curved corner portions 262 and 264, respectively, of thesecond portion 230 of the core housing assembly 218.

The end walls 318 and 320, side walls 322 and 324, corner walls 328 and330, and panel 326, define a cavity 332 configured to receive at least aportion of the hybrid circuit assembly 284. As shown, for example, inFIGS. 4D-4F, the hybrid circuit assembly 284 may include a PCB 334, afirst set 336 of additional circuitry components disposed on a firstsurface 338 of the PCB 334, and a second set 340 of additional circuitrycomponents disposed on a second, opposite, surface 342 of the PCB 334.The first and second surface 338 and 342 may be at least approximatelyparallel. As shown, the cavity 332 may include one or more raised floorsections 344 that correspond to another set 346 of circuitry componentshaving a lower profile with respect to the first surface 338 of the PCB334. In embodiments, the cavity may have a flat floor defined by thepanel 326. A raised block 348 having a window notch 350 defined thereinmay be disposed in the cavity 332 near the second end 314 of the corecircuitry support structure 282, corresponding to a portion of the firstsurface 338 of the PCB 334 having no additional circuitry components (oradditional circuitry components having a lower profile with respect tothe first surface 338). The window notch 350 may be aligned with awindow 352 defined in the panel 326. The window 352 may be configured toexpose a communication component 354 of the hybrid circuit assembly 284.The communication component 354 may include an antenna, an inductivecoil (e.g., for receiving wireless energy to recharge one or morebatteries), and/or the like.

As is further shown in FIGS. 3A-3E, the core circuitry support structure282 includes a number of alignment features 356 configured to engage,abut, and/or otherwise interface with, corresponding alignment notches358 defined in the PCB 334. Each alignment feature 356 may include a cap360 disposed at an end of a post 362 that extends away from a shelf 364.The shelf 364 extends along the periphery of core circuitry supportstructure 282 and is defined in the end walls 318 and 320 and the sidewalls 322 and 234. The PCB 334 is configured to be received into thecavity 332 such that a peripheral edge of the first side 338 of the PCB334 engages the shelf 364. The alignment features 356 are configured tobe received in the corresponding alignment notches 358, therebyfacilitating efficient and accurate alignment of the hybrid circuitassembly 284 within the core circuitry support structure 282 in amanufacturing setting. In this manner, for example, the hybrid circuitassembly 284 may be configured to fit together with the core circuitrysupport structure 282 in one orientation, to facilitate ease ofmanufacture.

As shown, for example, in FIGS. 3B, 3D, and 3E, the core circuitrysupport structure 282 may include three alignment features 356. In otherembodiments, the core circuitry support structure 282 may include one ortwo alignment features 356. In embodiments, the core circuitry supportstructure 282 may include more than three alignment features. Accordingto embodiments, at least one of the alignment features 356 may be of adifferent size and/or shape than at least one other alignment feature356. The cap 360 may, in embodiments, include a lip configured to engagea peripheral edge of the second surface 342 of the PCB 334 to facilitateholding the PCB 334 in place. In other embodiments, the cap 360 may beconfigured to function as a stop. The top of the cap 360 may, inembodiments, be at least approximately flush with the second surface 342of the PCB 334. The core circuitry support structure 282 also mayinclude one or more retaining clips 366 configured to engage aperipheral edge of the second surface 342 of the PCB 334 to facilitateholding the PCB 334 in place.

As shown, the core circuitry support structure 282 includes a firstspacer 368 extending from the first end wall 318 and configured tomaintain a space between the first end wall 318 and the firstfeed-through assembly 222; and a second spacer 370 extending from thesecond end wall 320 and configured to maintain a space between thesecond end wall 320 and the second feed-through assembly 226. Notches372 defined in the second end wall 320 may provide room for feed-throughcircuitry and/or other components such as, for example, batteryterminals 373. As shown in FIG. 3A and FIGS. 5A and 5B, a recess 374 maybe defined in the panel 326 and configured to receive an x-rayidentification tag 376. The x-ray identification tag 376 may be disposedin the recess 374 using an adhesive, laser welding, etching, and/or thelike.

As used herein, the terms “side wall,” “lower wall,” “upper wall,”“upward,” and “downward” are used to refer to the specific features towhich they refer, but are characterized in the context of theillustrations for clarity and to describe relative orientations offeatures with respect to other features, and are not intended to implyany particular orientation of the IMD 200, or absolute (or preferred)orientations of features thereof. That is, for example, even if the IMD200 were to be rotated around a longitudinal axis such that the outersurface 234B of the side wall 234 was parallel to a horizontal plane,the side wall 234 would still be referred to, for the purposes of thisdisclosure, as a “side wall.”

According to embodiments, core circuitry support structures may bedesigned according to any number of other configurations. FIGS. 6A and6B depict another core circuitry support structure 600 configured toreceive a hybrid circuitry assembly 602 in accordance with embodimentsof the disclosed subject matter. The core circuitry support structure600 may be designed to facilitate injection molding, which may, inembodiments, reduce costs of manufacturing the component.

As shown, the core circuitry support structure 600 includes a first end604 configured to be disposed adjacent a first feed-through assembly(e.g., the feed-through assembly 222 depicted in FIGS. 2A-2D), and asecond end 606 configured to be disposed adjacent a second feed-throughassembly (e.g., the feed-through assembly 226 depicted in FIGS. 2A-2D).The core circuitry support structure 600 includes a frame 608 having afirst end wall 610 disposed at or near the first end 604 of the corecircuitry support structure 600, a second end wall 612 disposed at ornear the second end 606 of the core circuitry support structure 600, andtwo parallel, opposed side walls 614 and 616 extending between the firstand second end walls 610 and 612. In embodiments, in contrast withembodiments discussed above with regard, for example, to FIGS. 3A-3E,the frame 608 may not include a panel extending between the walls 610and 612. In other embodiments, the frame 608 may include a panel,oriented at least approximately perpendicular to the walls 610, 612,614, and 616, and extending between the first and second end walls 610and 612. In embodiments, the frame 608 may include curved corner walls618 and 620, and each may be designed to have any desirable radius ofcurvature such as, for example, a radius of curvature that is identicalor similar to (or otherwise designed to complement/correspond to) theradius of curvature of each of the curved corner portions 262 and 264,respectively, of the second portion 230 of the core housing assembly218. As shown in FIGS. 6A and 6B, the frame 608 may also include angledupper corner walls 622 and 624.

The end walls 610 and 612, side walls 614 and 616 define a cavity 626configured to receive at least a portion of the hybrid circuit assembly602. The hybrid circuit assembly 602 may include a PCB 628, a first set(not shown) of additional circuitry components disposed on a firstsurface 632 of the PCB 628, and a second set 634 of additional circuitrycomponents disposed on a second, opposite, surface 636 of the PCB 628.The first and second surfaces 632 and 636 may be at least approximatelyparallel.

As is further shown in FIGS. 6A and 6B, the core circuitry supportstructure 600 includes a number of alignment features 638, 640, 642, and644 configured to engage, abut, and/or otherwise interface with,corresponding alignment notches 646, 648, 650, and 652, respectively,defined in the PCB 628. A first shelf portion 654 extends along theinside of the first wall 610 between the first side wall 614 and thesecond side wall 616. A second shelf portion 656 extends along theinside of the second wall 612 between the first side wall 614 and thesecond side wall 616. The PCB 628 is configured to be received into thecavity 626 such that a peripheral edge of a portion of the first side632 of the PCB 628 engages the first shelf portion 654 and a peripheraledge of another portion of the first side 632 of the PCB 628 engages thesecond shelf portion 656.

The alignment features 638, 640, 642, and 644 are configured to bereceived in the corresponding alignment notches 646, 648, 650, and 652,thereby facilitating efficient and accurate alignment of the hybridcircuit assembly 602 within the core circuitry support structure 600 ina manufacturing setting. To facilitate this alignment, as shown, atleast one alignment feature may have a different size and/or shape thanat least one other alignment feature. For example, three of thealignment features 638, 640, and 642 may all have a similar or identicalshape, while a fourth alignment feature 644 may have a shape that isdifferent than the shape of the other three alignment features 638, 640,and 642. Similarly, at least one of the corresponding alignment notchesmay have a different size and/or shape than at least one other alignmentnotch (e.g., in a manner corresponding to the alignment features). Thatis, for example, the corresponding alignment notches 646, 648, and 650,may all have a similar or identical shape, while the fourth alignmentnotch 652 may have a shape that is different than the shape of the otherthree alignment notches 646, 648, and 650. In this manner, for example,the hybrid circuit assembly 602 may be configured to fit together withthe core circuitry support structure 600 in one orientation, tofacilitate ease of manufacture.

As shown, for example, in FIGS. 6A and 6B, the core circuitry supportstructure 600 may include four alignment features 638, 640, 642, and644. In other embodiments, the core circuitry support structure 600 mayinclude one or two alignment features. In embodiments, the corecircuitry support structure 600 may include more than three alignmentfeatures. Additionally, as shown in FIGS. 6A and 6B, and in contrast toembodiments described above, the core circuitry support structure 600does not include retaining clips or a thinned area for an x-rayidentification tag. The lack of these features, in embodiments, mayfacilitate ease of manufacture such as by injection molding.

Embodiments of an IMD having a core circuit support structure configuredto receive a hybrid circuit assembly are described above, and includeconfigurations designed to enhance the internal volume of the IMD. FIG.7 is a flow diagram depicting an illustrative method 700 ofmanufacturing an IMD in accordance with embodiments of the disclosure.The IMD may be, for example, the IMD 102 depicted in FIG. 1, the IMD 200depicted in FIGS. 2A-2E, and/or the like.

Embodiments of the method 700 include providing a hybrid circuitassembly (block 702), which may include obtaining and/or assembling oneor more portions of a hybrid circuitry assembly such as, for example, byassembling an integrated circuit, coupling circuitry to a printedcircuit board (PCB), and/or the like. The method 700 also includesforming a core circuitry support structure (block 704) and coupling thehybrid circuitry assembly to the core circuitry support structure toform a core circuitry assembly (block 706). The core circuitry supportstructure may be formed using any number of different process such as,for example, stereo lithography, injection molding, additivemanufacturing (e.g., 3D printing), and/or the like. Forming the corecircuitry assembly may also include coupling a cover to the corecircuitry support structure.

The method 700 also may include providing a header (block 708), whichmay include obtaining and/or assembling one or more portions of a headersuch as, for example, by arranging circuit components (e.g., anelectrode and an antenna) on a scaffold assembly and enclosing thescaffold assembly within a header assembly housing. The method 700 mayalso include providing a battery assembly (block 710) and providingfeed-through assemblies (block 712), which may include obtaining and/orassembling a battery assembly and/or a first and second feed-throughassembly.

As depicted in FIG. 7, embodiments of the method 700 also includecoupling the feed-through assemblies to the core circuitry assembly(block 714), coupling the header to a first feed-through assembly (block716), and coupling the battery assembly to a second feed-throughassembly (block 718). In embodiments, the method 700 includes formingfirst and second portions of a core assembly housing (block 720). Inembodiments, the core assembly housing portions may be molded, cut,and/or the like, and may be identical or similar to the core assemblyhousing portions 228 and 230 depicted in FIGS. 2A-2C. As shown in FIG.7, embodiments of the method 700 also include positioning the coreassembly housing portions around the core circuitry assembly (block 722)and welding the core assembly housing portions together (block 724).

Various modifications and additions can be made to the exemplaryembodiments discussed without departing from the scope of the disclosedsubject matter. For example, while the embodiments described above referto particular features, the scope of this disclosure also includesembodiments having different combinations of features and embodimentsthat do not include all of the described features. Accordingly, thescope of the disclosed subject matter is intended to embrace all suchalternatives, modifications, and variations as fall within the scope ofthe claims, together with all equivalents thereof.

We claim:
 1. A medical device comprising: a housing for the medicaldevice; a printed circuit board (PCB) positioned in the housing andincluding alignment notches; and a support structure positioned in thehousing and including: a frame with outer walls that define a cavity,wherein at least a portion of the PCB is positioned within the cavity,and alignment features respectively protruding from the outer walls andthrough at least a portion of the alignment notches.
 2. The medicaldevice of claim 1, wherein the alignment features are positioned atcorners of the frame.
 3. The medical device of claim 1, wherein thesupport structure includes exactly four alignment features.
 4. Themedical device of claim 3, wherein the PCB includes exactly fouralignment notches.
 5. The medical device of claim 1, wherein the outerwalls include: a first end wall, a second, opposite end wall, and a pairof parallel, opposed side walls, wherein the first end wall, second endwall, and side walls define the cavity.
 6. The medical device of claim5, wherein the first end wall defines a first shelf portion, wherein thesecond end wall defines a second shelf portion.
 7. The medical device ofclaim 6, wherein the PCB rests on the first shelf portion and the secondshelf portion.
 8. The medical device of claim 1, wherein at least one ofthe alignment features is shaped and sized differently than anotheralignment feature.
 9. The medical device of claim 1, further comprising:a first set of circuitry components coupled to a first surface of thePCB; and a second set of circuitry components coupled to a secondsurface of the PCB opposite the first surface, wherein the first set ofcircuitry components extend within the cavity.
 10. The medical device ofclaim 9, wherein the first set of circuitry components includes anantenna or an inductive coil.
 11. The medical device of claim 1, whereinthe frame is rectangular shaped.
 12. The medical device of claim 1,wherein the frame includes spacer arranged and shaped to maintain aposition of the frame with respect to the housing.
 13. The medicaldevice of claim 1, further comprising: a header having a first end and asecond end; and a feed-through assembly coupled to the second end of theheader, wherein the feed-through assembly is electrically coupledbetween the PCB and the header.
 14. The medical device of claim 13,wherein the header includes a first electrode and an antenna.
 15. Themedical device of claim 14, further including a second electrode on anopposite end of the housing from the header.
 16. The medical device ofclaim 15, further including a second feed-through assembly.
 17. Themedical device of claim 16, wherein the second feed-through assembly iselectrically coupled between the PCB and the second electrode.
 18. Themedical device of claim 17, further including a first conductor coupledbetween the PCB and the first feed-through assembly, and furtherincluding a second conductor coupled between the PCB and the secondfeed-through assembly.